Spinal Cord Injury Clinical Trial
Official title:
Evaluation of Transfer Technologies to Preserve Shoulder Function in SCI
This is a laboratory-based study to evaluate the risk of shoulder injury associated with transfers between wheelchair and vehicle in persons with spinal cord injury. Four new devices will be compared against an unassisted transfer.
Specific Aims:
The purpose of this 3 year laboratory-based randomized crossover study is to evaluate the
ergonomic effectiveness of four wheelchair/vehicle transfer assistive devices, including (1)
standard transfer board, (2) Glide n' Go, ( 3) Easy Reach Lift, and (4) Ryno Lift, and to
compare them to an unassisted manual transfer. We have targeted persons with paraplegia
(level of injury T2-L5) to standardize physical capabilities. Our research questions are:
1. Evaluate the impact of vehicle/wheelchair transfers on objective measures of shoulder
kinematics, kinetics, and muscle activity, for each of the participants.
2. Evaluate the impact of vehicle/wheelchair transfers on subjective measures of shoulder
pain, spasticity, perceived comfort, ease, efficiency, and safety.
3. Examine the effects of covariates (patient characteristics, SCI characteristics and
pain) on both objective and subjective outcome measures.
Background:
Upper limb pain and injury are highly prevalent in persons with a spinal cord injury (SCI)
who use a manual wheelchair for mobility. Historically, persons with paraplegia did not long
survive the trauma of their injury, but with advances in medicine and emergency services,
persons with SCI now have a life expectancy approaching that of the general population. For
persons with paraplegia, paralysis of the lower limbs necessitates an over reliance on the
upper limbs for performing wheelchair propulsion, transfers in/out of the wheelchair, and
other mobility-related tasks. Many years of overuse of the upper extremities leads to an
increased incidence of pain and cumulative trauma to the shoulders, elbows and wrists. Over
50% of persons with SCI have upper extremity pain; rotator cuff tears have been reported in
59-73%; and 40% have clinical evidence of carpal tunnel syndrome. Upper extremity
deterioration following years of compensating for the lack of functional lower limbs in
addition to their usual loading reduces quality of life, function, independence, and even
life expectancy following SCI. The two most stressful mobility tasks performed by persons
with paraplegia are wheelchair propulsion and wheelchair transfers. Several investigators
have examined upper extremity kinematics (joint motions) kinetics (joint forces and
torques), and muscle activity as determined by electromyography (EMG) among individuals with
SCI during wheelchair propulsion. Comparatively few studies have addressed wheelchair
transfers none of which offer an integrated kinematic, kinetic and EMG approach to
simultaneously examine joint angles, moments and muscle activity.
Methods:
Using Vicon motion analysis technology, we propose a laboratory-based randomized evaluation
of five vehicle transfer approaches: unassisted manual transfer, standard transfer board,
Glide n'Go, Easy Reach lift, and Ryno lift. The selected commercially-available products
represent the range of assistive technologies presently available for this task.
A sample of 58 veterans with paraplegia, who use a manual wheelchair for mobility, will be
recruited to participate in this study. Subjects will be recruited from the Tampa VA
Hospital by means of poster advertisement. Participants will complete data collection
activities during one four-hour session, for which they will be compensated. Subjects will
be asked to perform a series of five randomized wheelchair-to-vehicle transfer tasks. Vicon
markers placed on the participant's body will capture positional data. Dynamic external
loads exerted during the transfer tasks will be measured using AMTI MC3A tri-axial load
cells strategically mounted in a vehicle mock-up. EMG will be recorded bilaterally for major
muscle groups. Participants will complete subjective rating scales upon completion of each
of the transfers.
The results of this study will be used to develop a clinical algorithm to assist clinicians
with the selection of the most appropriate assistive technology for persons with
disabilities who use a manual wheelchair for mobility. This algorithm will facilitate the
individualized selection of assistive technologies that minimize risk for injury and
maximize patient compliance, comfort, and satisfaction. The ultimate goal of this program of
research is to (1) promote successful adaptation to aging with a disability, (2) reduce
morbidity and mortality associated with wheelchair use, (3) enhance health-related quality
of life, patient freedom, function, independence, and confidence, and (4) reduce healthcare
utilization and associated costs.
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